Contactless electric cardiogram system

ABSTRACT

A system for providing a standard electrocardiogram (ECG) signal for a human body using contactless ECG sensors for outputting to exiting medical equipment or for storage or viewing on a remote device. The system comprises a digital processing module (DPM) adapted to connect to an array of contactless ECG sensors provided in a fabric or the like. A selection mechanism is embedded into the DPM which allows the DPM to identify body parts using the ECG signals of the different ECG sensors and select for each body part the best sensor lead. The DPM may then produce the standard ECG signal using the selected ECG signals for the different body parts detected. The system is adapted to continuously re-examine the selection to ensure that the best leads are selected for a given body part following a movement of the body part, thereby, allowing for continuous and un-interrupted ECG monitoring of the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 14/893,293, which was filed Nov. 23, 2015, as aNational Stage Application under 35 U.S.C. 371 of InternationalApplication No. PCT/CA2015/050938, filed Sep. 23, 2015, which claims thebenefit to both U.S. provisional patent application 62/206,542 filed onAug. 18, 2015 and U.S. provisional patent application 62/054,189 filedon Sep. 23, 2014, the specifications of which are hereby incorporated byreference.

BACKGROUND (a) Field

The subject matter generally relates to electro-cardiogram systems.

(b) Related Prior Art

Electrocardiograms (hereinafter ECG's) are the only reliable measurementof heart rate, arrhythmia detection, resting ECG abnormalities thatnecessitate mandatory further testing, changes from previous ECG's.

The ECG is one of the basic diagnostic and follow up screening toolsused in medicine for a large number of cardiac and non-cardiac diseases.While the standard 12-lead electrocardiogram holds a wealth ofinformation, it only captures data for 10 seconds. Long term monitoringwith multiple leads provides even more information and leads to betteraccess to changes in the electrocardiogram.

The lack of long term monitoring is an important medical problem formultiple reasons. The lack of a baseline electrocardiogram in apatient's file often results in confusion and needless additional examsin patients who have ECGs done for the first time which are normal forthem, but abnormal according to established criteria. Often, if an oldECG, even one from 10 years prior, is available that is the same as theperceived abnormal ECG, no further exams are required. In other words,the ability to compare a current ECG to an old one is of immense medicalvalue. An unchanged one results in fewer examinations.

Traditional electrocardiographic measurement systems that rely oncontact electrodes (electrodes which form a galvanic connection with thepatient's body) present challenges when ECG monitoring is requiredimmediately, unobtrusively or frequently. Traditional contact electrodesrequire placement by a trained healthcare provider on a clean, preparedskin surface to ensure accurate location (and therefore morphology) andsignal quality. Limitations of standard wet gel contact electrodeplacement include placing them on the body correctly and removing themwithin their time limit to avoid skin reactions.

Apart from their inability to provide long term monitoring, theiravailability is also limited as discussed below.

Ideally, ECGs should be performed on all patients as part of the routinemedical visit, especially if the patient has symptoms that necessitatemedical attention. However, the availability of the test is limited.Their availability is limited due to the cost of the ECG equipment andthe un-availability of the technicians needed to perform the test onpatients to put the leads on the patient correctly. With respect to ECGcosts, most physicians do not invest in having the test on site. Even inhospitals, telemetry units are limited to about 6 to 10 units locatedoutside of the intensive care units for the entire patients in a largehospital.

Another disadvantage is that standard electrodes have multiple problemsthat limit proper and widespread use of the ECG. These problems are:

-   -   1. The electrodes react with the skin due to the metal, gel, and        adhesive reactions, which requires multiple changes during a        hospital stay;    -   2. The lack of knowledge required to correctly place the        electrodes;    -   3. The time for placing the electrodes;    -   4. The complications associated with extended monitoring such as        when the electrodes fall off regularly due to sweat, patient's        movement, improper placement, etc;    -   5. ECG's derived using standard electrodes are prone to muscular        artifacts that result in false ECG's.

A further disadvantage is that the electrocardiogram obtained withstandard electrodes is labor and material intensive. Even a telemetryunit can take, in certain cases, upwards of 2-3 hours per day perpatient of nursing time to install and re-install standard electrodes.

Yet a further disadvantage is that ECGs are a source of nosocomialinfection spread in hospitals because of wires and their contact withnursing and hospital staff, and frequent nursing attention to theelectrodes.

Accordingly, there is a need in the market for a system and method whichaddress the shortcomings addressed above.

SUMMARY

The embodiments describe an ECG system which allows for frequent,inexpensive and accessible recording of ECG data from any patient orperson easily, unobtrusively and quickly by eliminating the need tomanually identify and prepare areas on the patient's body for contactsensors and to place sensors on those areas. The described systemcircumvents issues associated with contact electrodes by beingcontactless and by allowing multi-hour, multiple lead monitoring on adaily basis and for life.

In one aspect, there is provided a medical apparatus (aka DPM) forproviding electrocardiogram (ECG) signals for a human body usingcontactless ECG sensors, the medical apparatus comprising: an inputadapted to receive contactless ECG signals from an array of contactlessECG sensors; a processor adapted to perform a selection processincluding: detecting body parts located in proximity of the array ofcontactless ECG sensors; associating a group of contactless ECG sensorswith each detected body part; selecting from each group a contactlessECG sensor having a highest signal quality; the processor being adaptedto produce a standard ECG signal based on the received contactless ECGsignal of each selected contactless ECG sensor; and an output forsending the standard ECG signal.

The Medical apparatus may be a lightweight portable device that weighsless than 2 lbs.

In an embodiment, the selection process further comprises the steps of:obtaining a body outline of the human body using the contactless ECGsignals associated with the contactless ECG sensors located in proximityof the human body; determining a position of the human body on the arrayof contactless ECG sensors; dividing the contactless ECG sensors intogroups and associating each group to a body part using the body outlineand the position of the human body; and from each group, selecting thecontactless ECG sensor providing the contactless ECG signal having thehighest quality.

In an embodiment, the processor may identify the contactless ECG sensorsthat are located in close proximity to the human body by measuring animpedance between each contactless ECG sensor and the human body.

In another embodiment, the medical apparatus may be adapted to selectanother contactless ECG sensor for a given body part following amovement of the human body with respect to the array of contactless ECGsensors. In a further embodiment, the processor may be adapted to re-runthe selection process continuously to perform the selection of the othercontactless ECG sensor. The processor may also be adapted tocontinuously monitor a signal quality of the selected contactless ECGsensor associated with each body part to re-run the selection processwhen the signal quality drops beyond a given threshold.

The medical apparatus may comprise different operation modes comprising:a contactless mode which outputs a first standard ECG signal resultingfrom the contactless ECG signals; a hybrid mode which outputs a secondstandard ECG signal resulting from the contactless ECG signals andconventional ECG signals received from conventional contact electrodes;and a bypass mode which outputs a third standard ECG signal resultingfrom conventional ECG signals received from conventional contactelectrodes.

The medical apparatus may further comprise an automatic gain controlmechanism adapted to control relative impedance differences betweendifferent contactless ECG sensors and absolute impedance of eachcontactless ECG sensor to the human body due to a difference in distanceor clothing materials between each contactless ECG sensor and the humanbody.

A wired/wireless data port may be provided for transmitting the standardECG signal to a remote device over a data network.

In another aspect, a system for providing electrocardiogram (ECG)signals for a human body using contactless ECG sensors, the systemcomprising: a senor pad comprising an array of contactless ECG sensors;a processor operatively connected to the sensor pad and adapted toreceive contactless ECG signals from the contactless ECG sensors andperform a selection process including: detecting body parts located inproximity of the array of contactless ECG sensors; associating a groupof contactless ECG sensors with each detected body part; selecting fromeach group a contactless ECG sensor having a highest signal quality; theprocessor being adapted to produce a standard ECG signal based on thecontactless ECG signal of each selected contactless ECG sensor; and anoutput for sending the standard ECG signal.

In an embodiment, the sensor pad comprises a grounding pad for placingin proximity of and at distance from the human body, the grounding padbeing adapted to provide a capacitively coupled ground reference to thehuman body for reducing interference.

In another embodiment, the grounding pad may be driven with a feedbacksignal derived from the contactless ECG signals.

The system may further comprise a drive signal generator configured tofeed the grounding pad with a high frequency signal that is outside ofan ECG frequency band for determining the capacitively coupled groundreference for each contactless ECG sensor.

In an embodiment, the contactless ECG sensor may comprise: a capacitiveelectrode adapted to be capacitively coupled to the human body foroutputting an electrical charge which is representative of an electricalcardiac activity; an electrodynamic sensor configured to detect andamplify the electrical charge produced by the capacitive electrode; andan electrode shield physically provided in proximity of the electrodefor reducing a stray interference at an input of the electrodynamicsensor.

The contactless ECG sensor may me made of a flexible material.

In an embodiment, the sensor pad may be provided in a fabric with whichthe human body comes in contact.

In a further aspect, there is provided a method for providingelectrocardiogram (ECG) signals for a human body using contactless ECGsensors, the method comprising: receiving contactless ECG signals froman array of contactless ECG sensors; detecting body parts located inproximity of the array of contactless ECG sensors; associating a groupof contactless ECG sensors with each detected body part; selecting fromeach group a contactless ECG sensor having a highest signal quality; andproducing a standard ECG signal based on the contactless ECG signal ofeach selected contactless ECG sensor.

The method may further comprise obtaining a body outline of the humanbody using the contactless ECG signals associated with the contactlessECG sensors located in proximity of the human body; determining aposition of the human body on the array of contactless ECG sensor;dividing the contactless ECG sensors into groups and associate eachgroup to a body part using the body outline and the position of thehuman body; and from each group, selecting the contactless ECG sensorproviding the contactless ECG signal having the highest quality.

In an embodiment, the method further comprises identifying thecontactless ECG sensors that are located in close proximity to the humanbody by measuring an impedance between each contactless ECG sensor andthe human body.

The method may further repeat the steps of detecting to selectingcontinuously for selecting another contactless ECG sensor for a givenbody part following a movement of the human body with respect to thearray of contactless ECG sensors. In on embodiment, it is possible tocontinuously monitor a signal quality of the selected contactless ECGsensor associated with each body part and repeat the steps of detectingto selecting for selecting another contactless ECG sensor for a givenbody part when the signal quality drops beyond a given thresholdfollowing a movement of the human body with respect to the array ofcontactless ECG sensors.

The following terms are defined below:

The term lead is intended to mean a difference in measured voltagebetween two locations on the human body that provide and show PQRSTUwaveforms.

The term ECG lead is intended to mean a medically defined ECG signalbased on a difference in measured voltage between two medically definedlocations on the human body.

Standard ECG signal is an ECG signal that interfaces with existingmedical equipment and conforms to ECG standards. A standard ECG signalmay include a single rhythm strip or any number of standard medicallydefined ECG leads.

A rhythm strip is any lead that shows the rhythm between the PQRSTUwaveforms. The rhythm strip does not require that the ECG signal betaken from the medically defined ECG locations.

Features and advantages of the subject matter hereof will become moreapparent in light of the following detailed description of selectedembodiments, as illustrated in the accompanying figures. As will berealized, the subject matter disclosed and claimed is capable ofmodifications in various respects, all without departing from the scopeof the claims. Accordingly, the drawings and the description are to beregarded as illustrative in nature, and not as restrictive and the fullscope of the subject matter is set forth in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages of the present disclosure will becomeapparent from the following detailed description, taken in combinationwith the appended drawings, in which:

FIG. 1 is a block diagram of an exemplary ECG system in accordance withan embodiment;

FIG. 2 illustrates a non-limiting example of a sensor matrix inaccordance with an embodiment;

FIG. 3 is a flowchart illustrating the main steps performed by theselection algorithm, in accordance with an embodiment;

FIG. 4 illustrates an example of a full PQRST waveform obtained for apatient using a system in accordance with an embodiment;

FIG. 5 illustrates how the senor array captures ECG signals withoutdirect contact with the patient's skin;

FIG. 6 is a block diagram illustrating an exemplary sensor design of acontactless ECG sensor, in accordance with an embodiment;

FIG. 7 illustrates an example of a physical design of a contactless ECGsensor, in accordance with an embodiment;

FIG. 8 illustrates an exemplary block diagram of an overall design of asystem in accordance with an embodiment;

FIG. 9 is a block diagram illustrating an exemplary gain controlmechanism, in accordance with an embodiment

FIG. 10 is an exemplary block diagram illustrating the function of theRLD generator, in accordance with an embodiment

FIG. 11 shows medically recognized ECG locations for obtaining standardECG leads;

FIG. 12 illustrates an example of standard ECG leads, each lead beingshown as a vector between two locations on the human body;

FIGS. 13a & 13 b illustrate an example of how the system determines thebody outline of the patient; and

FIG. 14 is flowchart of a method for providing electrocardiogram (ECG)signals for a human body using contactless ECG sensors.

It will be noted that throughout the appended drawings, like featuresare identified by like reference numerals.

DETAILED DESCRIPTION

A system for providing a standard electrocardiogram (ECG) signal for ahuman body using contactless ECG sensors for outputting to exitingmedical equipment (as well as to new/dedicated monitors, or for viewingon a display device associated with a computing device) or for storageor viewing on a remote/local device. The system comprises a digitalprocessing module (DPM) adapted to connect to an array of contactlessECG sensors provided in a fabric or the like. A selection mechanism isembedded into the DPM which allows the DPM to identify body parts usingthe ECG signals of the different ECG sensors and select for each bodypart the best sensor lead. The DPM may then produce the standard ECGsignal using the selected ECG signals for the different body partsdetected. The system is adapted to continuously re-examine the selectionto ensure that the best leads are selected for a given body partfollowing a movement of the body part, thereby, allowing for continuousand un-interrupted ECG monitoring of the patient.

The present invention will be more readily understood by referring tothe following examples which are given to illustrate the inventionrather than to limit its scope.

Referring now to the drawings, FIG. 1 is a block diagram of an exemplaryECG system 200 in accordance with an embodiment. As shown in FIG. 1 thesystem 200 comprises an array of contactless sensors provided in asensor pad 7 (in a non-limiting example of implementation), and adigital processing module (DPM) 2 which is operatively connected to thearray of sensors using a cable 9 for obtaining sensor readings from thesensors provided in the pad 7. The DPM 2 may be configured tosimultaneously record the electrophysiological activity of the heart(body surface potential map) as well as identify the bestelectrodes/sensors to output a standards ECG signal (+posteriorprecordials) into existing medical equipment (6). The DPM may beconnected to a mobile device (3) or the cloud (4) via the internet or adata network to make the data readily available for doctors and inreal-time so that doctors can quickly diagnose arrhythmic and ischemicchanges detected by the DPM 2.

In a non-limiting example, the DPM 2 may be provided as a lightweightportable medical device which weighs about 2 lbs or less and may becarried around for performing the continuous ECG monitoring.

As stated above, the DPM 2 may be configured to produce an output signalwhich conforms to existing medical standards so that the output signalis identical to those that are acquired by a standard contact ECG systemand may be viewed/read using existing medical equipment 6 in a plug andplay manner (whereby no changes are to be made to the existing medicalequipment to read and output the standard ECG signal received from theDPM). The DPM 2 may include a data output plug adapted to receive astandard cable (8) to output a signal that be simultaneously read usingan existing medical equipment 6. The DPM 2 may also be able tosimultaneously record contact ECG information if a standard trunk cable5 is attached.

However, the DPM 2 may also have its own display device embedded in itor associated with it and may be adapted to send/stream the standard ECGsignal via a communications/data network to make the standard ECG signalavailable on a local/remote personal computer or portable device.

It should be noted that FIG. 1 illustrates a non-limiting example ofimplementation. Changes to the system 200 are possible without departingfrom the scope of the invention as defined in the claims. For example,although FIG. 1 illustrates cables for communicating the data betweendifferent modules, it is also contemplated that wireless connections maybe used including but not limited to: Wi-Fi, Bluetooth etc.

Furthermore, the sensor array may be in a variety of other objectsincluding: clothing, beds, and vehicle devices/components. In anotherexample, the sensor array may be provided in a plurality of devicesincluding but not limited to: furniture (e.g. chair, bed/mattress/cover,sofa, seat, mattress), in-vehicle devices (e.g. seat, headrest, steeringwheel etc.), or in a wearable device (e.g. jacket, shirt, t-shirt,sweater, bra etc.).

Selection Algorithm

Traditional ECG dictates electrode locations that are based onphysiology of the patient whereby traditional contact electrodes areadhered to these locations, maintaining relative body positionregardless of the patient's movement. For example, the V1 electrodeshould be placed on the 4^(th) intercostal space to the right of thesternum, the RA electrode should be placed on the right arm, the LAelectrode on the same location as the RA electrode but on the left armthe RL electrode should be placed on the right leg, lateral calf muscleand so on . . . as exemplified in FIG. 11. The importance of theseelectrodes and their locations lies in the fact that the difference involtage between two specific locations represents a medically definedECG lead (as discussed with respect to FIG. 11 and 12), and the lead inelectrocardiography represents a vector along which the heart'sdepolarization is measured and recorded to produce theelectrocardiogram.

Therefore in order to produce an ECG signal that is compatible withtraditional ECG standards it is necessary to follow the same principlealthough data is being collected in a contactless manner.

FIG. 2 illustrates a non-limiting example of a sensor matrix 202 inaccordance with an embodiment. As shown in FIG. 2 the matrix 202comprises n columns and m rows of sensors 10 arranged in a matrixconfiguration such that no matter how the patient is placed on thematrix 202, there would always be at least one sensor at a location onthe patient's body that corresponds to the physical placement of aconventional ECG electrode. Using an adaptive algorithm embedded in theDPM 2, the matrix 202 may be used for obtaining a continuous ECG readingby selecting a given sensor 10 form the matrix 202 which corresponds toa defined ECG location on the patient's body.

FIG. 3 is a flowchart illustrating the main steps performed by the arrayalgorithm 204, in accordance with an embodiment. At step 210 thealgorithm detects which sensors 10 are in close proximity to thepatient's body, by measuring the impedance between each sensor 10 andthe patient. This allows for detecting the sensors 10 that can be usedto obtain data from. ECG signals output by these sensors 10 (the onesdetermined to be in close proximity of the body) are then analyzed toobtain a body outline of the patient.

In a non-limiting example of implementation, the embodiments may usedifferent types of information to obtain the body outline. The firsttype is the coupling impedance which represents the distance between thebody and the sensor. When the coupling impedance is too high, the sensoris too far from the body and cannot be used. The second type is thesignal itself e.g. morphology of the signal and how the signal lookslike to see whether the signal has the usual ECG pattern or not (PQRSTUwaveforms). The third type of information relates to the geometricallocations of the ECG sensors providing good ECG signals. These sensorsand their location provide an indication on the geometrical shape of thehuman body as exemplified in FIGS. 13a and 13 b. in the example of FIG.13 a, assuming that a user 250 is laying down on a mattress having thesensor pad 202 embedded therein, the sensors 10 a that are in proximityof the patient's body will obtain a good ECG signals while the sensors10 b outside of the patient's body will not obtain a good signal. Basedon this information and the location of each sensor on the pad 202, theDPM 2 may obtain an outline 252 of the patient's body from which the DPMmay determine the shape, width and other dimensions of the patient'sbody as exemplified in FIG. 13b . Using this information and a set ofrules embedded in the DPM 2, the DPM 2 may then detect/determinelocations of body parts and associate one or more sensors 10 with eachbody part/body location for ECG purposes as discussed below.

At step 212 the algorithm analyses the ECG signal received from thesensors and combines it with the body outline already detected to findthe position of the patient's body on the pad. At step 214 thealgorithms performs a mapping of where on the body each sensor 10 islocated using the information obtained from steps 210 and 212. Oncegroups of sensors are found to be near each major body part for ECGpurposes (Right Arm, Left Arm, etc.), the signals from those adjacentsensors are compared and filtered at step 216 to select a single sensorwith the best ECG signal to receive and record therefrom ECG data forthat respective body part.

In an embodiment, the DPM 2 may be adapted to run the algorithm 204continuously and dynamically in order to re-examine the readingsobtained from the sensors 10 in real time to re-verify the selection ofthe sensor 10 having the best ECG reading to constantly take intoconsideration the patient's movement whereby a new sensor 10 may beselected which provides a better reading than the one previouslyselected before the movement.

In another embodiment, the system may detect when a patient moves anddetermines when it is necessary to run the algorithm again torecalculate whether or not a new selection needs to be made. Forexample, the system may monitor the signal's strength/quality anddetermine to re-run the selection algorithm 204 when the signal qualitydrops below a given threshold.

Detection of PQRSTU Waveforms

As discussed above, the system may be configured to record cardiacelectrophysiological activity and ECG. Specifically, the system may bedesigned to acquire the full PQRSTU spectrum constituent ECG waveformsas exemplified in FIG. 4 which illustrates an example of a full PQRSTUwaveform obtained for a patient using a system in accordance with anembodiment. The PQRSTU waveforms illustrated in FIG. 4 are generated bythe heart and captured by the system to be viewed by doctors fordiagnosis. In an embodiment, the system captures the ECG readings andprocesses them to produce ECG signals that may be read and viewed usingexisting medical equipment and produces waveforms that are identical tothose produced by standard contact ECG systems, and as such can be usedin place of standard ECG systems for all applications.

Needless to say, the contactless sensors 10 do not produce an outputthat is compatible with existing medical equipment's (e.g. monitors andthe like) and therefore cannot interface with these equipment, hence theneed for further processing. In an embodiment, the DPM converts theacquired signal into a format that complies with the internationalstandards for existing medical equipment. This allows for a seamlessreplacement of conventional contact ECG systems without the need toreplace existing diagnostic medical devices or re-train doctors andmedical professionals. Such conversion may be performed in the DPM 2using a combination of digital signal processing and analog outputcircuitry in the Digital to Analog Converter stage (19).

Sensor Design

As discussed above, the embodiments obtain ECG readings of the patientusing contactless ECG sensors 10. The sensors 10 are specificallydesigned to capture high quality ECG from a patient without requiringdirect electrical contact with the patient's skin. This allows to placethe sensors 10 at some distance from the patient and/or to be separatedfrom the patient's skin by a fabric such as clothing, bedding, etc. asexemplified in FIG. 5 which illustrates an example of how the senorarray captures ECG signals without direct contact with the patient'sskin.

FIG. 6 is a block diagram illustrating an exemplary sensor design inaccordance with an embodiment. As shown in FIG. 6 the sensor 10 mayinclude a conductive electrode 33, an electrode shield 32, and anelectrodynamic sensor including an amplifier 34 and a bias circuit 35voltage. In the exemplary design of FIG. 6, the gain/current bufferingamplifier 34 may be used in a type of negative feedback topology, andthe input bias network 35 is adapted to increase the effective inputimpedance of the amplifier 34, to preserve the signal quality of theacquired ECG. The input of the electrodynamic sensor is connected to theconductive electrode 33. A shield driving circuitry (36) may be employedto generate a feedback signal to connect to the electrode shield (32) tofurther increase the signal to noise (SNR) ratio by reducing parasiticcapacitance seen at the input of the electrodynamic sensor.

The electrode 33 may be capacitively coupled to the patient's body bybeing in proximity to, but not touching the skin/body. This can beaccomplished by laying on a bed with an array of sensors 10 embedded init (as non-limiting example of implementation), while clothed. Theelectric field near the surface of the patient's skin that is createdfrom the electrical activity of the heart capacitively induces a chargeon the conductive electrode 33 without direct electrical contact. Thischarge may then be collected and amplified by the electrodynamic sensor,which produces an electrical signal (voltage) that is representative ofthe electrical activity of the heart in that location (complete PQRSTU).

The electrode shield 32 is configured to reduce the amount of strayinterference that the electrodynamic sensor receives and also decreasethe effective capacitance of the input of the amplifier 34, which helpsto preserve signal quality of the acquired ECG.

In an non-limiting example of implementation, both the electrode 33 andthe electrode shield 32 may be made of an elastic/flexible materialwhich allows the sensor 10 to better adapt to the geometry of the humanbody and obtain better ECG readings. At the same time this configurationallows the sensors 10 to be seamlessly provided in the fabric (or any ofthe following: gel/silicone/rubber type pad/mat etc.) in which thesensor array is to be placed.

FIG. 7 illustrates an example of a physical design of the sensor 10. Asexemplified in FIG. 7, the physical design includes the conductiveelectrode 33 physically implemented as a layer 39, the shield 32physically implemented as the layer 40, and the remaining of thecircuitry embedded in the layer 41. The entire structure may be producedon a substrate 37 which may also be a printed circuit board, forexample. In the design illustrated in FIG. 7, the layers 39, 40 and 41may be insulated from each other by dielectric layers 38 to provideelectrical insulation.

FIG. 8 illustrates an exemplary block diagram of an overall design of asystem in accordance with an embodiment.

Referring to FIG. 8, and as discussed above with respect to FIG. 1, thesystem may include a sensor pad 7 comprising contactless ECG sensors(hereinafter CECG sensors 10) which may be provided in the form of anarray 202 such as that shown in FIG. 2. The sensor pad 7 may alsoinclude a grounding pad 15, a driving circuitry e.g. a right leg drive(RLD) generator 14 (discussed below), and an A/D converter 13. Thesensor pad 7 outputs the digitized ECG readings of the sensors 10 to theDPM 2. The RLD generator 14 is configured to feed the grounding pad 15with a high frequency signal that is outside of the ECG frequency band.This high frequency signal is then coupled through the patient's body tothe CECG sensors, where the amplitude is recorded and analyzed by theDPM 2. This gives the system a metric of how well-coupled each sensor isto the patient, effectively an impedance measurement to determine whatthe signal quality is from each sensor.

In addition to the digitized CECG sensor data, the DPM 2 may also beconfigured to receive standard ECG data of conventional electrodes in ananalog format. Such analog ECG data is optionally acquired through theuse of standard contact electrodes and a trunk cable (5). The analogsignals may be converted using an ADC 17. The signals may then befiltered using a digital signal processing unit 18, and output over avariety of wired and wireless interfaces (Wi-Fi (22)/Ethernet (23) to amobile app (3)/cloud server (4) and through the ‘Analog CECG & ECG out’interface to existing medical equipment (6)).

The DPM 2 may include some sort of non-volatile memory e.g. flash memory26 for storage of ECG data (if necessary). The DPM 2 may also beconfigured to perform diagnosis for acute issues, and send a warningover any one of the communication interfaces or an integrated soundalarm (24). The DPM 2 may also include a Bluetooth Low Energy interface(21) to enable configuration by the user through a mobile device. A ReadOnly Memory (25) may also be included to store a unique identifier. ACryptographic processing module (27) may also be used to encrypt anddecrypt data transmitted/received through the communication interfaces,and securely stores keys for this data encryption.

All sensor data (contactless and contact) can be sent over the wired andwireless interfaces. The array algorithm 204 (discussed above in FIG. 3)decides which sensor information should be output over the analoginterface 19 to existing medical equipment. A relay 20 may be providedto switch between the analog data received from the conventionalelectrodes and the contactless sensors 10 and to allow the DPM 2 tocompare between the two. In DPM 2 can be configured to be turned off toact like a pass-through cable, without affecting the contact ECG signalif desired (controlled by the Processing Unit and Relays (20)). It canalso be used in ‘hybrid mode’, during which a combination of CECG andECG sensors can be output over the analog interface, if it improves thequality of the ECG signal.

Automatic Gain Correction

Due to the large, yet finite, input impedance of theelectrophysiological sensors 10, variations in the capacitive couplingbetween each sensor 10 and the patient's body (e.g. changes in thedistance between each sensor and the body) can cause variations in thegain of each sensor channel. This has the effect of affecting theamplitude of ECG leads, in the same way that a dried out contactadhesive electrode produces a lower quality signal than a new one. Toaddress the problem, a gain control mechanism is provided which allowsthe system to control relative impedance differences between differentcontactless ECG sensors, and an absolute impedance between eachcontactless ECG sensor and the human body due to a difference indistance between each contactless ECG sensor and the human body. Asshown in FIG. 9, a programmable gain amplifier 43 (either in the analogor digital domains) may be provided on each sensor channel 42 to offsetthe change in gain caused by differences in coupling between the sensors10 and the patient. FIG. 9 is a block diagram illustrating an exemplarygain control mechanism in accordance with an embodiment. As shown inFIG. 9, the gain control mechanism 220 may include a feedback loopincluding an ADC 44 coupled between the PGA 43 and a processor 45 whichitself is connected to the PGA 43 to control its gain in real-time asthe change is occurring.

The processor 45 may be a dedicated processor and may also be aprocessor module embedded into the processing unit 18 of the DPM 2.

Right Leg Drive

Referring back to FIG. 8, a grounding pad 15 is shown which in operationshould be placed near, but not in contact with (at a distance), thepatient's body. This pad is driven with a feedback signal derived fromthe ECG signals to provide a capacitively coupled ground reference tothe patient's body. The feedback signal is derived in such a way toincrease the common mode rejection ratio (CMRR) of the system (by over10 dB, typically). This reduces interference from common mode signalsand preserves the signal quality of the acquired ECG.

FIG. 10 is an exemplary block diagram illustrating the function of theRLD generator 14, in accordance with an embodiment. As shown in FIG. 10,data received from the sensors is selected (or discarded) using aswitching matrix (29) which selects specific sensors 10 to obtain datafrom using an RLD algorithm implemented digitally in the processing unit(18). The signals are then summed (29), inverted and amplified (30).This constitutes the driving signal for the grounding pad 15.

The RLD algorithm is configured to monitor the common mode signalacquired from each sensor (and by extension, the ECG signals output fromselection algorithm). The RLD algorithm may select the set of sensorsthat increases the common mode rejection ratio of the system after theRLD signal is applied to the patient in the feedback configuration.

Acquired Leads

As discussed above, the ability to compare a current ECG to an old oneis of an immense medical value and this is not possible with existingsystems which do not allow for long term monitoring. For example, anabnormal ECG does not prove acute cardiac disease, and a normal ECG doesnot exclude cardiac disease. It is therefore necessary to compare newECG with ECG's made in the past. Hallmarks may include

Is there a change in rhythm?

Is there a change in frequency?

Is there a change in conduction time?

Is there a change in heart axis?

Are there new pathological Q's?

Is there a change in R wave size?

Is there a change in ST?

Is there a change in T wave?

The above changes immediately result in further investigations. Changesin the electrocardiogram can be further classified as acute and chronic,however, both require comparison electrocardiograms.

In general, as the number of electrodes used increases, the monitoringtime that is possible decreases. Currently, one major limitation of thecurrent standards is the difficulty in obtaining long term monitoringwith multiple electrodes due to the inherent limitation of placingmultiple electrodes and maintaining them on the body.

The system described above allows for serial comparison ofelectrocardiograms for the first time. The system has proven to acquireposterior ECG leads. According to a modified Mason-Likar lead system, a16 lead ECG can be acquired from the patient laying on the matrix ofsensors, embedded in a mattress, chair, etc,. The acquired leadsinclude: Leads I, II, III, aVr, aV1, aVf, V1, V1R, V2, V2R, V3, V3R, V4,V4R, V5, V5R as exemplified in FIG. 11 and FIG. 12. FIG. 11 showsmedically recognized ECG locations for obtaining standard ECG leads, andFIG. 12 illustrates an example of standard ECG leads, each lead beingshown as a vector between two locations on the human body.

The pad including the sensors 10 can be placed, unperceivably under amattress so that ECG data can be acquired from posterior leads; e.g. theprone position. The system may be based on the Mason-Likar sensorplacement used for the acquisition of the ECG during stress testing.Standard 12 lead ECG placement is not used because of myopotentials,motion, artifacts, etc. and is limited to the 10 second 12 lead ECGprintout and is not practical for short to long term monitoring.

Posterior placed electrodes are an accepted method of ECG acquisition,and indeed are used as an adjunct in certain situations to the morecommonly used method of anterior lead placements. Anterior leadplacement is currently the only type of lead placement used because ofconvenience. However, prone position ECG leads are performed in certainsituations with standard electrodes, but because of the inherentdifficulties, is not a standard.

FIG. 14 is a flowchart of a method for providing electrocardiogram (ECG)signals for a human body using contactless ECG sensors. As shown inFir.14, the method 260 begins at step 262 by receiving contactless ECGsignals from an array of contactless ECG sensors. Step 264 comprisesdetecting body parts located in proximity of the array of contactlessECG sensors. Step 266 comprises selecting from each group a contactlessECG sensor having a highest signal quality. Step 268 comprises producinga standard ECG signal based on the contactless ECG signal of eachselected contactless ECG sensor.

While preferred embodiments have been described above and illustrated inthe accompanying drawings, it will be evident to those skilled in theart that modifications may be made without departing from thisdisclosure. Such modifications are considered as possible variantscomprised in the scope of the disclosure.

1. A device for providing electrocardiogram (ECG) signals for a humanbody, the device comprising: a processor adapted to operably connect toa sensor array including a plurality of contactless ECG sensors toreceive a plurality of contactless ECG signals for the human body, theprocessor being adapted to perform the steps of: obtaining a bodyoutline of a portion of the human body detected by the sensor array;detecting one or more body parts located in the body outline using a setof rules; associating a group of contactless ECG sensors with eachdetected body part; selecting from each group a contactless ECG sensorhaving a highest signal quality for the body part associated with thatgroup of contactless ECG sensors; the processor being adapted to producea standard ECG signal based on the contactless ECG signals received fromthe selected contactless ECG sensors.
 2. The device of claim 1, whereinthe processor is further adapted to perform the steps of: a. identifyinga group of contactless ECG sensors that are in close proximity of thehuman body; b. dividing the identified group of contactless ECG sensorsinto sub-groups and associating each sub-group to a body part; and c.from each sub-group, selecting the contactless ECG sensor providing thehighest signal quality.
 3. The device of claim 2, wherein the processoridentifies the contactless ECG sensors that are located in closeproximity to the human body by measuring an impedance between eachcontactless ECG sensor and the human body.
 4. The device of claim 1,wherein the processor is adapted to select another contactless ECGsensor for a given body part following a movement of the human body withrespect to the array of contactless ECG sensors.
 5. The device of claim4, wherein the processor is adapted to continuously monitor a currentsignal quality of the selected contactless ECG sensor associated witheach body part to select the other contactless ECG sensor when thecurrent signal quality drops beyond a given threshold.
 6. The device ofclaim 1, wherein the processor is adapted to continuously monitor acurrent signal quality of the selected contactless ECG sensor associatedwith each body part to select another contactless ECG sensor when thecurrent signal quality drops beyond a given threshold.
 7. The device ofclaim 1, further comprising an automatic gain control mechanism adaptedto control relative impedance differences between different contactlessECG sensors, and an absolute impedance between each contactless ECGsensor and the human body due to a difference in distance or type ofclothing material between each contactless ECG sensor and the humanbody.
 8. The device of claim 1, further comprising an input forconnecting to the sensor array.
 9. The device of claim 1, furthercomprising a wired/wireless data port for transmitting the standard ECGsignal to a remote/local storage device and/or display device.
 10. Asystem for providing electrocardiogram (ECG) signals for a human bodyfor storage and/or viewing on a remote/local device, the systemcomprising: a fabric including a sensor pad comprising an array ofcontactless ECG sensors; a processor operatively connected to the sensorpad and adapted to receive contactless ECG signals from the contactlessECG sensors, the processor being adapted to perform the steps of:obtaining a body outline of a portion of the human body detected by thesensor array; detecting one or more body parts located in the bodyoutline using a set of rules; associating a group of contactless ECGsensors with each detected body part; selecting from each group acontactless ECG sensor having a highest signal quality for the body partassociated with that group of contactless ECG sensors; the processorbeing adapted to produce a standard ECG signal based on the contactlessECG signals received from the selected contactless ECG sensors.
 11. Thesystem of claim 10, wherein the sensor pad comprises a grounding pad forplacing in proximity of and at distance from the human body, thegrounding pad being adapted to provide a capacitively coupled groundreference to the human body for reducing interference.
 12. The system ofclaim 11, further comprising a drive signal generator configured to feedthe grounding pad with a high frequency signal that is outside of an ECGfrequency band for determining the capacitively coupled ground referencefor each contactless ECG sensor.
 13. The system of claim 10, wherein thecontactless ECG sensor comprises: a capacitive electrode adapted to becapacitively coupled to the human body for outputting an electricalcharge which is representative of an electrical cardiac activity; anelectrodynamic sensor configured to detect and amplify the electricalcharge produced by the capacitive electrode; and an electrode shieldphysically provided in proximity of the electrode for reducing a strayinterference at an input of the electrodynamic sensor.
 14. The system ofclaim 13, wherein the contactless ECG sensor is made of a flexiblematerial.
 15. The system of claim 13, wherein the sensor pad is providedin a fabric with which the human body comes in contact or in one of: agel, silicone, a rubber type pad, and a mat.
 16. A method for providingelectrocardiogram (ECG) signals for a human body using contactless ECGsensors, the method comprising: receiving contactless ECG signals froman array of contactless ECG sensors; obtaining a body outline of aportion of the human body detected by the sensor array; detecting one ormore body parts located in the body outline; associating a group ofcontactless ECG sensors with each detected body part; selecting fromeach group a contactless ECG sensor having a highest signal quality forthe body part associated with that group of contactless ECG sensors;producing a standard ECG signal based on the contactless ECG signalsreceived from the selected contactless ECG sensor.
 17. The method ofclaim 16, further comprising: identifying a group of contactless ECGsensors that are in close proximity of the human body; dividing theidentified group of contactless ECG sensors into sub-groups andassociating each sub-group to a body part; and from each sub-group,selecting the contactless ECG sensor providing the highest signalquality.
 18. The method of claim 17, further comprising identifying thecontactless ECG sensors that are located in close proximity to the humanbody by measuring an impedance between each contactless ECG sensor andthe human body.
 19. The method of claim 16, further comprising:repeating the steps of detecting to selecting continuously for selectinganother contactless ECG sensor for a given body part following amovement of the human body with respect to the array of contactless ECGsensors.
 20. The method of claim 16, further comprising continuouslymonitoring a current signal quality of the selected contactless ECGsensor associated with each body part; and when the current signalquality drops beyond a given threshold following a movement of the humanbody with respect to the array of contactless ECG sensors, repeating thesteps of detecting, associating and selecting to select anothercontactless ECG sensor for at least one of the body parts.
 21. Themethod of claim 16, further comprising controlling relative impedancedifferences between different contactless ECG sensors, and an absoluteimpedance between each contactless ECG sensor and the human body due toa difference in distance or a type of clothing material between eachcontactless ECG sensor and the human body.